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Pilates as an Adjuvant Therapy in Parkinson Disease.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03294031
Recruitment Status : Completed
First Posted : September 26, 2017
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):
Gustavo Rodríguez Fuentes, University of Vigo

Brief Summary:
Although Pilates has been proposed as a useful rehabilitation strategy in PD, research on its feasibility and potential effects on the motor symptoms and balance with this population is scarce. Some works have included Pilates as part of combined exercise session interventions, but information concerning their specific effects was not provided. Under these circumstances, this study aims at identifying the effects of adding Pilates as part of a conventional exercise rehabilitation program on the motor symptoms and static balance of PD persons. Participants (n=15) were assigned to a Pilates (PG) or to a conventional exercise group (CG) and performed one land-based and one water-based exercise session per week for 14 weeks. The MDS-UPDRS and a stabilometer were used to assess the impact of the intervention on the participant´s motor symptoms and static balance.

Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Pilates Other: Conventional Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pilates as an Adjuvant Physical Exercise Therapy in Patients With Parkinson Disease.
Actual Study Start Date : January 11, 2016
Actual Primary Completion Date : May 27, 2016
Actual Study Completion Date : May 27, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pilates
The Pilates program covered a 12-week period, two weekly sessions. In one session, exercises were performed on a mat (Mat Pilates), and in the second session in standing and sitting position. The programme included warm-up exercises, the main part of the session and cooling activities.
Other: Pilates
Warm-up exercises included Abdominal and costal breathing and Pelvic Clock. Some exercises included in the main part of the mat session were Arm arcs, Curls up, Femur arcs, Shoulder bridge, Leg circles, among others. The main part of the sitting/standing session included in standing position exercises like Standing on one leg with support, Neck rolls, Side leg lift with support and in sitting position Spine stretch 5", Elbows back with hands behind his head, Heel/knee slides, Shoulder drops, Knee folds, among others. In mat sessions, cooling exercises included in standing position Hamstring stretch and Abdominal Breathing and Rest position and in sitting/standing session Stretching and Abdominal Breathing.

Active Comparator: Conventional Exercise
The conventional exercise programme covered a 12-week period, two weekly sessions. The programme aimed at improving aerobic capacity, muscular resistance, balance and flexibility. The program combined land-based and water-based exercise sessions.
Other: Conventional Exercise
All sessions started with a 15-minute warm-up phase based on walking performance and joint mobility exercises. It was followed by a 35-minute second phase, which included low-impact aerobics (music tempo was set at 120 beats per minute), gross motor coordination tasks and balance activities. The final 5-minute phase focused on gentle stretching exercises.




Primary Outcome Measures :
  1. Motor impairment. [ Time Frame: The participants were assessed one week before starting the program (week #0). ]
    The Spanish adapted version of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) was administered to assess the impact of the intervention on the motor impairment and disability related to PD. The MDS-UPDRS total score ranges from zero to 200, with higher scores indicating a greater impact of PD symptoms.


Secondary Outcome Measures :
  1. Anthropometric Measurements. [ Time Frame: The participants were assessed one week before starting the program (week #0). ]
    The height (cm) and weight (kg) of the participants were measured without shoes and in light clothing. The body mass index (BMI) was calculated using the following formula: weight / height2 (kg/m2).

  2. Change from baseline Anthropometric Measurements at week 15. [ Time Frame: The participants were assessed one week after the programme was completed (week #15). ]
    The height (cm) and weight (kg) of the participants were measured without shoes and in light clothing. The body mass index (BMI) was calculated using the following formula: weight / height2 (kg/m2).

  3. Change from week 15 Anthropometric Measurements at week 18 follow-up. [ Time Frame: Follow-up assessment was performed four weeks after training ended (week #18). ]
    The height (cm) and weight (kg) of the participants were measured without shoes and in light clothing. The body mass index (BMI) was calculated using the following formula: weight / height2 (kg/m2).

  4. Static Balance at baseline. [ Time Frame: The participants were assessed one week before starting the program (week #0). ]
    The static balance was evaluated using the TecnoBody Prokin 3 platform. The assessment protocol was developed in a sitting and standing position, with open (OE) and closed (CE) eyes. The participants had three 30-second attempts to perform the position with open and closed eyes and a 60-second interval of active rest between them. The static balance parameters assessed were the centre of pressure of the body in the frontal plane, the centre of pressure of the body in the sagittal plane, the amplitude movement of the centre of pressure in the sagittal plane, the amplitude movement of the centre of pressure in the frontal plane, the average speed of oscillation movement of the centre of pressure in the sagittal plane, the average speed of oscillation movement of the centre of pressure in the frontal plane, the sum of distances of the amount of movement of the centre of pressure, and the displacement area of the centre of pressure.

  5. Change from baseline Static Balance at 15 weeks. [ Time Frame: The participants were assessed one week after the programme was completed (week #15). ]
    The static balance was evaluated using the TecnoBody Prokin 3 platform. The assessment protocol was developed in a sitting and standing position, with open (OE) and closed (CE) eyes. The participants had three 30-second attempts to perform the position with open and closed eyes and a 60-second interval of active rest between them. The static balance parameters assessed were the centre of pressure of the body in the frontal plane, the centre of pressure of the body in the sagittal plane, the amplitude movement of the centre of pressure in the sagittal plane, the amplitude movement of the centre of pressure in the frontal plane, the average speed of oscillation movement of the centre of pressure in the sagittal plane, the average speed of oscillation movement of the centre of pressure in the frontal plane, the sum of distances of the amount of movement of the centre of pressure, and the displacement area of the centre of pressure.

  6. Change from week 15 Static Balance at week 18 follow-up. [ Time Frame: Follow-up assessment was performed four weeks after training ended (week #18). ]
    The static balance was evaluated using the TecnoBody Prokin 3 platform. The assessment protocol was developed in a sitting and standing position, with open (OE) and closed (CE) eyes. The participants had three 30-second attempts to perform the position with open and closed eyes and a 60-second interval of active rest between them. The static balance parameters assessed were the centre of pressure of the body in the frontal plane, the centre of pressure of the body in the sagittal plane, the amplitude movement of the centre of pressure in the sagittal plane, the amplitude movement of the centre of pressure in the frontal plane, the average speed of oscillation movement of the centre of pressure in the sagittal plane, the average speed of oscillation movement of the centre of pressure in the frontal plane, the sum of distances of the amount of movement of the centre of pressure, and the displacement area of the centre of pressure.

  7. Change from baseline Motor Impairment at 15 weeks. [ Time Frame: The participants were assessed one week after the programme was completed (week #15). ]
    The Spanish adapted version of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) was administered to assess the impact of the intervention on the motor impairment and disability related to PD. The MDS-UPDRS total score ranges from zero to 200, with higher scores indicating a greater impact of PD symptoms.

  8. Change from week 15 Motor Impairment at week 18 follow-up. [ Time Frame: Follow-up assessment was performed four weeks after training ended (week #18). ]
    The Spanish adapted version of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) was administered to assess the impact of the intervention on the motor impairment and disability related to PD. The MDS-UPDRS total score ranges from zero to 200, with higher scores indicating a greater impact of PD symptoms.



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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stages 1 through 3 on the Hoehn and Yahr Staging Scale;
  • Stable reaction to anti-Parkinson medication;
  • Not having taken part in any physical exercise program during the month prior to the study.

Exclusion Criteria:

  • People with PD who were not able to ambulate independently or presented any comorbidities other than PD or any acute illness that would make training inappropriate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294031


Sponsors and Collaborators
University of Vigo
Investigators
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Study Director: José María Cancela-Carral, Ph.D. University of Vigo
Publications of Results:
Lange C, Unnithan VB, Larkam E, Latta PM. Maximizing the benefits of Pilates-inspired exercise for learning functional motor skills. Journal of Bodywork and Movement Therapies 4: 99-108, 2000.

Other Publications:
Johnson L, Putrino D, James I, Rodrigues J, Stell R, Thickbroom G, Mastaglia FL. The effects of a supervised Pilates training program on balance in Parkinson's disease. Advances in Parkinson Disease 2: 58-61, 2013.

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Responsible Party: Gustavo Rodríguez Fuentes, Ph.D., University of Vigo
ClinicalTrials.gov Identifier: NCT03294031    
Other Study ID Numbers: 2015/484
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gustavo Rodríguez Fuentes, University of Vigo:
Parkinson Disease
Neurodegenerative Disorder
Physical Activity
Pilates Method
Stabilometer
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases